Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days: The "Early Hydrocortisone Group" will be receiving Hydrocortisone since the diagnosis of shock and the vasoactive drugs are initiated.

Vasoactive drug therapies: This group will receive the treatment that the attending physician will decide. It may include any kind of vasoactive drug and, at some point, Hydrocortisone if the attending considers the patient is going through a "Vasoactive resistant shock".

Study summary

The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g. The main questions it aims to answer are:

* Does the early use of hydrocortisone help solve shock in preterm infants under 1500 g faster than the standard treatment?
* Does the early use of hydrocortisone help prevent death within the first seven days of presentation of shock in comparison to premature infants who receive regular treatment?

Researchers will compare the early use of hydrocortisone plus the standard treatment to solve shock against just standard treatment.

Participants will:

* Be randomized to receive standard treatment for shock according to their neonatologist or this standard treatment plus hydrocortisone as soon as the diagnosis is done and treatment is started.
* Be followed either until shock is solved or if they present death due to this event of shock.

Eligibility

Primary outcome measure(s)

• Shock resolution — 72 hours
  The patient is hemodynamically stable and no longer requires vasoactive support.

Trial sites (1)

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